Kornimate/medical-research-clean huggingface dataset:
timing of laparoscopic cholecystectomy after endoscopic retrograde cholangiography for acute biliary pancreatitis

Conditions: Cholelithiasis Associated With Common Bile Duct Stones

Summary: timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography for acute biliary pancreatitis is a controversial issue. there are still many confounding findings offering either early laparoscopic cholecystectomy within 72 hours following endoscopic sphincterotomy or delayed surgery after 6 weeks. peritoneal plasmin system is known to be an important factor in peritoneal healing and adhesion formation. measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.

peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion formation. it is expected that endoscopic retrograde cholangiography is a trauma causing adhesions around the hepatobiliary area. such adhesions may cause some difficulty for consequent gallbladder surgery. for that reason, tissue measurements of factors indicating degree of peritoneal healing and adhesion is helpful for timing of such surgical interventions. patients are going to be randomized to early and delayed surgery groups. sampling of peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after endoscopic retrograde cholangiography is performed. tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are going to be studied by using commercial assays. peritoneal fibrinolytic activity and surgical outcomes are going to be compared.

Eligibility criteria:
inclusion criteria: * cholelithiasis following endoscopic retrograde cholangiography for acute biliary pancreatitis exclusion criteria: * contraindication to laparoscopy * unsuccessful endoscopic retrograde cholangiography * complicated acute biliary pancreatitis

Keywords: cholelithiasis laparoscopic cholecystectomy endoscopic sphincterotomy choledocholithiasis
patient self monitoring to evaluate 30 day post discharge heart failure outcomes

Conditions: Heart Failure

Summary: the purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with hf. the primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.


Eligibility criteria:
inclusion criteria: 1. \> 65 years of age 2. male and female patients admitted to the hospital with the primary diagnosis of hf with hospitalization \> 24 hours 3. able to read and write in english 4. discharged to home environment exclusion criteria: 1. a cardiac transplant candidate 2. experienced an acute coronary event within the previous 30 days of index hospitalization 3. experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization 4. end stage renal disease/hemodialysis 5. have a left ventricular assist device 6. \> 400 lbs 7. unable to stand for 90 seconds independently
risk stratification procedure for thromboembolism prophylaxis

Conditions: Total Knee Replacement Surgeries

Summary: the main objective for this study is validation for the proposed risk stratification tool, by evaluating the clinical outcomes for its use post tkr surgeries. for this objective, the design that is used is randomized trial.

all patients that will have total knee replacement, in a given period of time in both medical centers; prince sultan military medical city (psmmc) and king abd allah university hospital (kaauh) in princess noura university, will be randomly separated into 2 groups; in the first group (a): venous thromboembolism (vte) risk stratification tool (which is prepared by a clinical pharmacist) will be applied to choose the tailored extended vte prophylactic agent. while in the second group (b), the risk stratification tool will not be used, rather it will follow the routine hospital protocol for choosing the vte prophylactic agent, which is caprini: a standard validated model. then each group of patients will be followed till 35 days post-operation, during which all vte or bleeding events should be recorded.

Eligibility criteria:
inclusion criteria: 1. male or female patients who are planned for elective tkr surgery (primary only). 2. agreed to sign the informed consent form (icf). 3. patients aged older than 18 years. exclusion criteria: 1. patients receiving anticoagulant for treatment. 2. patients with a history of dvt or pe were excluded from the study due to the marked increase in the risk of recurrent vte compared to the general risk of (7% vs. 0.1%); (fahrni, 2015). 3. patients with renal or hepatic failure, renal failure is defined as end-stage kidney disease (on dialysis); hepatic failure is defined as complete liver cirrhosis. 4. pregnant woman. 5. revision surgeries.

Keywords: total knee replacement venous thromboembolism (vte) risk stratification
effect of perioperative lidocaine on gastrointestinal function recovery after lumbar spine surgery in adults

Conditions: Spinal Surgery; Lidocaine; Pain; Opioid Consumption; Gastrointestinal Dysfunction

Summary: spinal surgery often involves multiple segments. the trauma of surgery is large, the duration of postoperative pain is long, and the pain is severe. therefore, the use of opioids in perioperative period is large. although the application of \* large amounts of opioids can effectively inhibit pain, it will delay the recovery of urine retention, sedation, respiratory depression and gastrointestinal function. the delayed recovery of gastrointestinal function will increase the postoperative complications, and then increase the length of hospital stay and the cost of patients. therefore, reducing the dosage of opioids to promote the recovery of gastrointestinal function has become the research direction. intravenous lidocaine has been proved to be effective in reducing the dosage of opioids during the perioperative period of gastrointestinal surgery and promoting the recovery of postoperative gastrointestinal function. however, there are few studies on the application of lidocaine during the perioperative period of spinal surgery, especially the impact on postoperative gastrointestinal function. in this study, a multicenter, randomized, double-blind, controlled study was conducted to explore the effect of perioperative lidocaine on the recovery of gastrointestinal function after adult lumbar surgery. we hypothesized that lidocaine could shorten the recovery time of gastrointestinal function after lumbar surgery


Eligibility criteria:
inclusion criteria: 1. age 60 to 80; 2. asa physical status score of i, ii or iii; 3. scheduled to undergo a posterior lumbar surgery; 4. ideal body weight≤80 kg; exclusion criteria: 1. those who are refused to be included; 2. those who are allergic to the drugs used in this study; 3. emergency operation 4. degree ii or iii atrioventricular block 5. heart failure 6. history of als, preexcitation or active dysrhythmia 7. severe liver injury (bilirubin \> 1.46 mg/dl) 8. severe renal injury (creatinine clearance \< 30 ml/min) or renal failure 9. history of epilepsy 10. history of porphyria 11. preoperative hypotension (sbp\< 90mmhg) 12. drug contraindications of nsaids 13. allergic to anaesthetic

Keywords: lidocaine gastrointestinal dysfunction spinal surgery opioid consumption
value of urodynamic evaluation

Conditions: Urinary Incontinence

Summary: although no reliable and specific figures are available for the total expenditure on uds, uds is commonly performed for patients with urinary incontinence (ui) regardless of gender and age. uds is typically performed prior to incontinence surgery. urodynamic studies are expensive, time-consuming, and uncomfortable diagnostic investigations. the 3rd ici reported insufficient evidence with which to answer the following key research questions related to uds: 1) do physicians alter clinical decision-making based on results of uds?, and 2) do alterations in clinical decisions made in response to uds results improve the clinical outcomes?


Eligibility criteria:
inclusion criteria: 1. female 2. predominant sui as evidenced by all of the following: 1. self-reported stress-type ui symptoms, of duration \>3 months\* 2. mesa stress symptom score (percent of total possible stress score) greater than mesa urge symptom score (percent of total possible urge score) 3. observation of leakage by provocative stress test at any volume 4. eligible for randomization to either treatment group 5. eligible for sui surgery 6. desires non-conservative therapy for sui 7. pvr \<150ml by any method. (may repeat once if initial measure is abnormal) 8. negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative ua or negative culture 9. available to initiate sui treatment within 6 weeks of randomization 10. available for 12-months of follow-up and able to complete study assessments, per clinician judgment. 11. signed consent form. * patient can be rescreened after respective time interval has been met. exclusion criteria: 1. age \<21 years\* 2. currently undergoing or has had recommended treatment of apical or anterior prolapse 3. no anterior or apical prolapse \> +1 on standing straining prolapse exam 4. pregnant or has not completed child bearing. 5. \<12 months post-partum\*† 6. active malignancy of cervix, uterus, fallopian tube(s) or ovary \> stage i, or bladder of any stage 7. history of pelvic radiation therapy 8. previous incontinence surgery 9. current catheter use 10. neurological disease known to affect bladder storage (e.g. ms, parkinsonism, cva) 11. previous (i.e. repaired) or current urethral diverticulum 12. prior augmentation cystoplasty or artificial sphincter 13. implanted nerve stimulators for urinary symptoms or previous botox bladder injections. 14. any pelvic surgery within the last 3 months\* 15. previous placement of synthetic mesh on a vaginal approach in the anterior compartment 16. participation in another treatment intervention trial that might influence results of this trial. 17. a urodynamic result reviewed by the investigator in the preceding 12 months or any recollection by the investigator of urodynamic results on that subject. * patient can be rescreened after respective time interval has been met. * "partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.

Keywords: stress urinary incontinence, mixed, urge
evaluation of the efficacy of prophylactic topical gentamicin in tunnelled catheters for hemodialysis

Conditions: Hemodialysis Catheter Infection

Summary: chronic kidney disease (ckd) is a major public health problem worldwide, with a significant increase in the number of patients treated with dialysis and renal transplantation. hemodialysis (hd) is the most widely used dialysis therapy in the world, and adequate vascular access is required. the central venous catheter (cvc), although not considered the ideal vascular access, is still widely used. its use has a strong relation with access-related infection, whether it is an exit orifice (ies), a tunnel and the most severe, the bloodstream (bsi). consequently cvc contributes to patients' morbidity and mortality in hd, as well as to the high cost of hemodialysis treatment. to compare the use of 0.1% topical gentamicin with the use of placebo in the exit site (es) of tunneled catheters in patients in chronic hd regarding the reduction in ies and bsi rates and to identify the induction of bacterial resistance to gentamicin.

a randomized, double-blind clinical trial comparing the use of 0.1% gentamicin versus placebo in the es of tunnelled catheters for hemodialysis in the prevalence and density of incidence of ies and bsi. patients will be allocated into two groups randomly: group 1 (control): patients using placebo ointment in es; group 2 (intervention): patient using 0.1% gentamicin ointment in es.

Eligibility criteria:
inclusion criteria: * incident and prevalent patients on hemodialysis * tunnelled catheter implant within 90 days of study initiation exclusion criteria: * patients under 18 years of age * pregnant women * other types of access for dialysis other than tunnelled catheters * course of infection at the time of initiation of the study.

Keywords: hemodialysis; tunneled catheter central venous catheters infections prevention.
repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients

Conditions: Opioid-Related Disorders; Drug Overdose

Summary: reboot is a pilot randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients (reboot). it includes an established overdose education curriculum within an informational-motivation-behavior (imb) model. this study will test the feasibility of an efficacy trial of reboot vs treatment as usual (information and referrals) that will evaluate overdose events (non-fatal or death), drug use cessation, and overdose and hiv risk behaviors, among opioid-dependent persons who have previously overdosed and already received take-home naloxone (the opioid antagonist used to reverse overdose).


Eligibility criteria:
inclusion criteria: * age 18-65 years; * current opioid dependence by scid * urine positive for opioids during screening, excluding prescribed agonist maintenance therapy * history of prior opioid overdose * previously received take-home naloxone * no serious illnesses likely to progress clinically during trial * able and willing to provide informed consent, provide locator information, communicate in english, adhere to visit schedule exclusion criteria: * suicidal ideation by concise health risk tracking (chrt) * currently participating in another interventional research study that could possible impact the study's outcomes of interest * any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures

Keywords: clinical trial naloxone motivational interviewing
different cycles of capecitabine usage in esophageal cancer concurrent chemoradiotherapy

Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma

Summary: definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in western countries in esophagus cancer.but in china because of its toxic reaction, most of patients stop the halfway.because low toxicity, capecitabine is widely used in the chemotherapy of esophageal cancer. the purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.we are prepared to within 2 years study recruited 200 patients with esophageal cancer.the primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.

we recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the oct 2014. the the patients was divided into two groups. group 1: capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. group 2: capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.

Eligibility criteria:
inclusion criteria: * age 45-75years old * histologically proven squamous cell carcinoma of the esophagus * the tumor was in t2-4n0-2m0 * the patients have not received the surgery or chemo-radiotherapy. * hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l, * alt、ast≤2.5\*n,cr≤1.5\*n. * performance status score 0-2 exclusion criteria: * pregnant, lactating women * oxaliplatin or fluorouracil allergy or metabolic disorders * radiotherapy contraindications * history of organ transplantation * brain metastasis * the peripheral nervous system disorders * severe infection * oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding * severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * other malignant tumor in recent 5 years.

Keywords: chemoradiotherapy esophageal squamous cancer capecitabine
a comparative dissolution and absorption study of an orodispersible powder, chewable tablet and soft gel capsule vitamin d3 supplementation

Conditions: Vitamin D Deficiency

Summary: this is an open-labelled, randomized controlled clinical trial aimed to compare the pharmacokinetics of an orodispersible vs a soft gelatin vitamin supplementation in vitamin d deficient healthy adults.

vitamin d is a fat-soluble vitamin used by the body for normal bone development and maintenance by increasing the absorption of calcium, magnesium, and phosphate. vitamin d also plays a role in the nervous system, musculoskeletal system and immune system. vitamin d deficiency has been linked with diverse health conditions including diabetes, cardiovascular diseases, breast, colorectal and prostate cancer, dementia, depression, erectile dysfunction, osteoporosis, and bone disorders. vitamin d deficiency is a global healthcare challenge. to overcome vitamin d deficiency, a daily vitamin d supplementation of 200-1000 iu or a high dosage from 25000 to 200000 iu for 4-6 weeks, is normally recommended. vitamin d supplements are available over the counter in different delivery vehicles (formulations) to reach the circulatory system. in the present study the investigators aim to evaluate the pharmacokinetics of an orodispersible vitamin d supplement vs a conventional oral soft gelatin capsule, in vitamin d deficient healthy adults to assess how different vitamin d supplement formulations can efficiently overcome the vitamin d deficiency.

Eligibility criteria:
inclusion criteria: * healthy male and female adults aged 18 - 60 years * vitamin d deficiency as shown by serum levels of 25 (oh) d3 levels of \< 20 ng/ml * able to provide informed written consent exclusion criteria: * clinically significant abnormal laboratory parameters (such as complete blood count, crp, d-dimer, liver enzymes, creatinine) indicative of physical illness, especially hypercalcemia and hypercalciuria * history of hypersensitivity to vitamin d3 supplements * history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseases * prior use of medications in general containing calcium, magnesium, or vitamin d3, four weeks before the start of the study * participation in the evaluation of any investigational product or blood donations in the last three months before this study * any other significant disease or disorder that, in the opinion of the physician, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study
trial of microplasmin intravitreal injection for non-surgical treatment of focal vitreomacular adhesion. the mivi-trust (tg-mv-006) trial.

Conditions: Vitreomacular Adhesion

Summary: the objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.


Eligibility criteria:
inclusion criteria: * presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm optical coherence tomography (oct) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint) exclusion criteria: * any evidence of proliferative retinopathy (including proliferative diabetic retinopathy (pdr) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative age-related macular degeneration (amd) or retinal vein occlusion in the study eye. * subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either oct and/or fluorescein angiogram in the study eye. * subjects with macular hole diameter \> 400 μm in the study eye. * aphakia in the study eye. * high myopia (more than 8d) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length \>28 mm is an exclusion).
a phase i clinical study of shr-a2009 for injection in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is an open-label, multicenter phase i clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of shr-a2009 for injection in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 2. have at least one measurable tumor lesion per recist v1.1 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage); 3. ecog performance status of 0-1; 4. life expectancy ≥ 12 weeks; 5. adequate bone marrow and organ function . 6. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. exclusion criteria: 1. patients with symptomatic central nervous system metastases or meningeal metastases; 2. ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 3. prior treatment with antibody-drug conjugate (adc) consisting of topoisomerase i inhibitors; 4. history of serious cardiovascular and cerebrovascular diseases; 5. severe infection within 4 weeks prior to the first dose; 6. adverse reactions of previous anti-tumor treatment have not recovered to grade ≤ 1 per nci-ctcae v5.0.